Quality Excerpts 2003

8/9/2019 Quality Excerpts 2003

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Continual Improvement Using ISO 9001

Improvement loop advances quality but needs more work

by Sandford iebesman

One of t!e key additions to ISO 9001"#000 is a subclause $%&%1 requirement for continual

improvement% '!is requirement is a definite advance over ISO 9001"199() w!ic! relied only on

corrective and preventive action to improve t!e quality management system *+,S-%

Subclause $%&%1 requires t!e organi.ation to /continually improve t!e effectiveness of t!e +,S

t!roug! t!e use of t!e quality policy) quality obectives) audit results) analysis of data) corrective

and preventive actions and management review%/ If fully implemented) t!is plandoc!eckact cycle

s!ould result in iteration after iteration of improvement% 2irst) let3s look at eac! of t!e elements

of t!is improvement loop%

4olicy and obectives

'op management must ensure t!e quality policy *subclause &%5- /provides a framework for

establis!ing and reviewing quality obectives%/ '!us t!e policy must be translatable into measurable

obectives *subclause &%(%1- t!at include t!e ones needed to meet product requirements w!ile being

consistent wit! t!e quality policy% 'op management3s goals must be put into practice using

measurable obectives to stimulate improvement%

6udit results

'!e ne7t element in t!e improvement loop is t!e /results of audits/ step performed by t!e

organi.ation% '!is element includes internal audits defined in subclause $%#%#) peer audits) second

and t!irdparty audits and ot!er audits performed by t!e organi.ation% 6udit results provide one

tool for understanding t!e status of t!e +,S% '!e ot!er key tool is t!e analysis of data%

8ata analysis

Subclause $%( requires t!e organi.ation to /determine) collect and analy.e appropriate data to

demonstrate t!e suitability and effectiveness of t!e +,S%/ '!e data must also be used to evaluate

w!ere t!e effectiveness of t!e +,S can be improved%

'!e analysis must /provide information relating to customer satisfaction) conformity to productrequirements %%% and suppliers%/ '!e information must also relate to /c!aracteristics and trends of

processes and products/ and s!ould result in /opportunities for prevention action%/

ote t!is requirement identifies t!e need to translate data into information) w!ic! leads to

preventive action improvement opportunities%

4reventive and corrective actions


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4reventive actions *subclause $%&%5- are aimed at eliminating t!e cause of potential

nonconformities% '!e information from t!e data analysis s!ould result in identification of potential

root causes of future problems% Corrective action *subclause $%&%#-) on t!e ot!er !and) uses

information to eliminate causes of identified actual nonconformities and prevent t!eir recurrence%

:ot! actions are key to continual improvement in t!e organi.ation) but may result only in local) notglobal) c!anges% 'op management s!ould make t!e improvements global during t!e management

review process%

,anagement review

,anagement review *subclause &%;- is w!ere t!e elements of t!e improvement process are broug!t

toget!er% '!e review is aimed at ensuring /continuing suitability) adequacy and effectiveness/ of

t!e +,S% It s!ould result in opportunities for improvement and may lead to c!anges in t!e +,S)

including t!e quality policy and obectives%

Inputs to management review include audit results and t!e status of preventive and corrective

actions% Ot!er required inputs are information on customer feedback) process performance and

product conformity) previous management review followup actions) c!anges to t!e +,S and

recommendations for improvement%

,andatory outputs of t!e review are decisions and actions t!at s!ould result in improvements in

t!e effectiveness of t!e +,S) its processes and t!e organi.ation3s products% ,anagement review

is t!erefore t!e tool to assure improvement across t!e entire organi.ation% '!e results of

management review s!ould start t!e ne7t iteration of t!e improvement loop%

6ncillary requirements

Ot!er requirements t!at play an important role in effective continual improvement include planning)

communication) and monitoring and measurement activities%


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representative to report t!e performance of t!e +,S to top management and identify t!e need

for improvement%

,onitoring and measurement% '!e analysis of data is one of t!e elements of t!e improvement loop%

Subclause $%1 requires t!e organi.ation to /plan and implement

measurement) analysis and improvement processes %%% to continually improve t!e effectiveness oft!e +,S%/ Subclauses $%#%1) $%#%5 and $%#%( require monitoring and measurement of customer

satisfaction data) processes of t!e +,S and t!e organi.ation3s products%

Improvement loop problems

6lt!oug! t!e improvement loop is itself an improvement) t!ere are t!ree problems wit! it as

defined in ISO 9001"#000"

1% o process is required% Subclause $%&%1 states /t!e organi.ation s!all continually improve t!e

effectiveness of t!e +,S%/ 6s an auditor I ask) !ow is t!is done wit!out a process to specify t!e

met!odology>

#% Specifying /t!e organi.ation/ as responsible for t!e improvement loop is a vague statement

ignoring t!e real responsibility for improvement t!at lies wit! top management% I contend t!e

improvement loop belongs in clause &) close to t!e management review process%

5% ?ow do you measure improvement in t!e effectiveness of t!e +,S> @ffectiveness is defined in

ISO 9000"#000 as t!e /e7tent to w!ic! planned activities are reali.ed and planned results

ac!ieved%/


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representative could be responsible for its effective operation% '!e current requirement to

communicate t!e status of t!e +,S and t!e need for improvement would provide t!e direct link to

top management%

Is '!ere 'ime>

,eeting t!e ISO 9001"#000 transition deadline will be a c!allenge for some organi.ations

by Bo!n @% /Back/

'!ese issues may limit t!e ability of t!e registration system to get all organi.ations upgraded by

t!e deadline% :ut I also e7pect some organi.ations will simply decide not to continue to !old

certificates%


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Some organi.ations in markets wit! no real demand for registration may believe t!ey !ave already

derived all t!e value t!ey can from being registered% Ot!ers likely will be unwilling to make t!e

commitment or meet some of t!e c!anges in requirements% Indeed) it is my opinion t!at some suc!

fallout is desirable and could ultimately improve t!e credibility of t!e system%

Impact of C!anges

are !aving on organi.ations% '!is impact depends largely on t!e nature and focus of an

organi.ation3s current +,S%

6s 2igure 1 illustrates) t!e impact may be very slig!t for organi.ations wit! mature systems

focused on customers and continual improvement and driven by top management% It is quite a

different story for organi.ations t!at are internally focused or !ave uninvolved top management%

'!is group may find t!e c!anges daunting and t!eir effect profound%

Sector Specific Standards

Some organi.ations are in industries wit! a document t!at adopts ISO 9001 and adds industry

specific e7planations or requirements% 2or e7ample) many companies in t!e automotive industry are

registered to +S9000 and will ultimately make t!e transition to ISO'S 1;9(9"#00#% Ot!ers are

registered to ' 9000 for t!e telecommunications industry or 6S9100 for aviation and aerospace%

,ost suc! organi.ations !ave been registered to bot! ISO 9001"199( and t!e sector specific

document% '!e sector specific standard may !ave a later deadline t!an t!at for ISO 9001 itself%

,any of t!ese organi.ations view t!e deadline as t!at establis!ed wit!in t!eir own sector or may

elect to limit t!eir registration to only t!e sector document) foregoing or at least postponing

certification to ISO 9001"#000% In addition) many organi.ations in sectors wit! t!eir own standards


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!ave !ad to adopt fairly mature) customer focused +,Ss to meet earlier versions of t!eir

industry3s requirements%

,ature +,Ss

,any organi.ations !ave mature +,Ss t!at fully *or almost fully- comply wit! ISO 9001"#000%

'!ere !as been a tendency for some to wait until t!eir certificate is near e7piration and upgrade at

t!at time%

auditing into t!e last !alf of t!is year%

Organi.ations t!at are in t!is category absolutely need to get t!eir upgrade audits sc!eduled wit!t!eir registrar or t!ey will face a seemingly inevitable capacity problem%

:ut t!at is not t!e real problem%

transition on time) t!ose t!at wait until t!e last minute may !ave missed an ideal opportunity to

make a good +,S even better%


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#% Customer focus%

5% 'op management3s role%

(% 4rocesses vs% procedures%

1% Continual improvement%

'!en t!ere is t!e matter of t!e relations!ip of improvement to t!e setting of real measurable

quality obectives% Organi.ations wit! immature systems often !ave not yet made t!e effort to

determine !ow to effectively measure t!eir results% Organi.ations in t!is situation will need to

start small by developing a set of quality obectives t!at align closely wit! t!eir business

obectives%

#% Customer focus% 6n internally focused organi.ation needs to learn to focus on its customers% It

can be argued t!at t!e only real additional customer related requirement in ISO 9001"#000 is

measurement of customer satisfaction% :ut actually ISO 9001"#000 mentions customers muc! more

often t!an did t!e 199( standard) and it mentions customer satisfaction seven times%

5% 'op management3s role% I e7pect auditors for registrars will be spending a bit more time wit! top

managers to determine w!et!er t!ey are really carrying out all t!e activities required of t!em in

ISO 9001"#000% '!ey will need to be more fully engaged in making decisions related to t!e +,S

t!an ever before% It is time for quality professionals to quickly learn !ow to lead t!eir bosses%

(% 4rocesses vs% procedures% '!en t!ere is t!e little matter of t!e s!ift from ISO 9001"199(3s

procedure based system to ISO 9001"#0003s process based one%


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,uc! !as been written in +uality 4rogress about ISO 9001"#0003s process approac! to +,Ss)1 so

I will not describe w!at it takes to use t!e approac!% :ut it is t!e most important part of t!e

standard to get rig!t%


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2irst) w!at is a problem> In clause #%10) ISO 9000"#000 discusses t!e use of statistical

tec!niques in solving or preventing problemst!us improving effectiveness and efficiency%

'!e word /problem/ is found in ISO 900("#000 more often) a fact we will discuss later) but it isnot actually defined in t!e ISO 9000 family of documents% '!e ISO directives specify dictionaries

to be used for definitions of common terms not ot!erwise defined in ISO 9000 deliverables% One

dictionary defines /problem/ as /an unwelcome or !armful matter needing to be dealt wit! and

overcome) or a t!ing t!at is difficult to ac!ieve%/1 ,ost often problem solving is used in t!is

necessary but negative conte7t) for e7ample) in addressing nonconforming products or processes%

6not!er somew!at accepted definition of t!e term /problem/ is anyt!ing t!at deviates from w!at

is considered normal% In t!e conte7t of process management) t!is definition does not address

incapable processes%

2or e7ample) if an administrative process is designed so it works rig!t t!e first time $0G of t!e

time and meets management e7pectations) t!ere is no perceived problem% ,anaging t!e e7ceptions

is viewed as part of t!e ob% Suc! a view on t!e part of management was a matter of great concern

to


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In ISO 9001"#000) /problem/ is used in t!e more positive conte7t of preventing its occurrence as

opposed to preventing recurrence *corrective action-% 4roblems s!ould be viewed as opportunities

for improvement% '!us) problem solving s!ould be integral to improvementbot! continual

improvement and innovative improvement%

6ccording to ISO 900("#000) clause $%&%1) /,anagement s!ould continually seek to improve t!e

effectiveness and efficiency of t!e processes of t!e organi.ation) rat!er t!an wait for a problem

to reveal opportunities for improvement% Improvements can range from smallstep ongoing continual

improvement to strategic breakt!roug! improvements%/

2urt!ermore) ISO 900("#000) clause ;%#%#%# includes problem solving among t!e skills for w!ic!training s!ould be considered) and clause A%(%# recommends suppliers be evaluated) in part) for t!eir

performance in responding to problems%

,ost problem solving models !ave some common elements) suc! as identifying) containing) analy.ing

root cause) implementing action*s- and verifying t!e effectiveness of action*s- taken% ?owever)

t!ere is anot!er dimension to problem solvingcomple7ity%

4roblem Solving and Comple7ity

6ll problems are not created equal) as depicted in 2igure 1% 6n individual can solve some problems

alone% 2or ot!ers) !e or s!e will need !elp from ot!er individuals) teams or e7perts%

'!e bottom of t!e pyramid in 2igure 1 represents t!e simple problems individuals can solve

independently using t!eir e7pertise or available tools% 2or e7ample) a cut finger can be addressedby cleansing) application of an overt!ecounter antibiotic and application of a bandage% 6 mac!ine

s!op operator may note a trend in control c!art data over time indicating t!e deterioration of a

drill bit and t!e need for a bit replacement prior to failure%


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Opportunities for improvement at t!is level can result in continual improvementsmall incremental

improvements anyone can make on a daily basis%

'!e ne7t level of t!e pyramid represents problems too comple7 for an individual to solve alone% 6sinus infection may require a prescription antibiotic from your p!ysician% 6 near depletion of raw

material for a mac!ine operator due to nonconforming material in process may require earlier t!an

e7pected replenis!ment from a material !andling person%

6t t!is problem comple7ity level an individual needs t!e !elp of anot!era supervisor) peer or

subect matter e7pertto solve t!e problem% 4roblems in t!is category can also be opportunities

for continual improvement%

'!e ne7t level of problem comple7ity includes t!ose t!at require a cross functional team to solve%

'!ese problems can be quickly resolved wit! appropriate cross functional input leveraging t!e

intellectual capital in t!e organi.ation%

'!is is t!e type of problem solving alluded to by ISO 900("#000) clause ;%;) w!ic! talks about t!e

need to establis! twoway communication at appropriate levels wit!in organi.ations and t!eir

suppliers to provide /rapid solution of problems and to avoid costly delays or disputes%/

In t!e late 19$0s) Heneral @lectric developed and used a rapid cross functional process called


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obectives are met% '!ese top management representatives s!ould include e7perts% 4roblem

identification and correction are listed among items t!ese reviews s!ould include%

'!is is also t!e level in 2igure 1 *p% 90- w!ere innovation !appens% Organi.ations typically depend one7perts for innovative improvements) w!ic! occur sporadically but provide quantum leaps in

efficiency and effectiveness% '!is type of improvement takes time and muc! work compared to

continual improvements t!at can be made by everyone for problems of less comple7ity%

=6SIC *or =6SCI- C!arts

6 =6SIC *responsible) approves) supports) is informed and is consulted-) also known as =6SCI)c!art is a simple tool t!at can be used to identify roles and responsibilities in a process to make

sure owners!ip) approval) support) consultation and communication responsibilities are assigned% 6n

e7ample of a =6SIC is provided in 2igure #% Completing a =6SIC requires a detailed understanding

of t!e process% 6 =6SIC can be used effectively wit! process flowc!arts%

'!e =6SIC c!art !as only a few rules% Steps of a process are listed% One) and only one) person or

function is designated as responsible for eac! step% 6 person to be consulted for a given step

generally !as a stronger relations!ip to t!e responsible party t!an a person wit! a support role% It

is not necessary t!at eac! step !ave ot!er roles suc! as /approves/ or /is consulted/ designated%

Henerally) more process definition is better if it is applicable%

6nyone completing a =6SIC s!ould carefully consider w!o needs to be informed at eac! step of a

process% @ffective communication) especially in a large organi.ation) is difficult and must be planned

and provided for% '!is is one of t!e key benefits of a well designed document control process% It

will ensure t!ose w!o need to know do indeed know and t!ose w!o do not need to know will not%

6ccording to Back


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independent certification bodies to drive improvement in concert wit! accreditation bodies and

organi.ations3 customers%

4roblem identification is usually t!e first step in any disciplined problem solving model% In t!e

course of auditing) certification bodies) as part of a cross organi.ational team *2igure 1) levels 5()p% 90-) can !elp identify problems in t!e conte7t of opportunities for improvement% Organi.ations

!ave supplier quality and internal quality functions wit! resources to solve problems but are not

always aware of t!e opportunities t!at e7ist in t!eir supply c!ains%

'o address confidentiality issues between t!e certification bodies and t!eir clients) accreditation

bodies could provide a buffer for communication of appropriate information to customer

organi.ations% Corrective action by suppliers could t!en be prioriti.ed by customers based on t!e

significance of t!e problems) as recommended by ISO 900("#000) clause $%&%#% '!e result could be

improved quality and customer satisfaction wit! bot! supplier organi.ations and t!e t!irdparty

certification process%

Use ISO 900( 'o Improve 4erformance

It3s a powerful modern business management tool

by B%4% =ussell

ISO 900("#000 is a valuable tool for improving an organi.ation3s effectiveness) efficiency and t!e

quality of its products and services% It is a standalone document t!at s!ould be used for improving

organi.ation performance% +uality management and business principles are deeply rooted in it) and

t!ere are clausebyclause links to ISO 9001"#000%

'!e biggest misconception about ISO 900("#000 is t!at it is supposed to be used as an

implementation guide for ISO 9001% @ven t!oug! ISO 900( may promote a better understanding of

t!e intent of t!e ISO 9001 requirements) ISO 900( is muc! more valuable t!an t!at%


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ISO 900( was written for top management to use% ?owever) it is not written like a book or a

procedure% Instead) it is a tec!nical document top managers must study to know !ow to use it to

improve organi.ation performance) reduce costs) satisfy customers and improve competitiveness%

2ew quality professionals and managers seem to understand t!e tremendous opportunity ISO 900(

represents% ,ost are still struggling wit! /w!at good is it>/ and /w!y use it>/ questions%

6ssess Dour Organi.ation

ISO 900( can be used for selfassessment to determine !ow your organi.ation compares to t!e

performance improvement guidelines% '!e standard is a collection of statements indicating w!at t!eorgani.ation s!ould do% '!e s!oulddo statements can be used to create a c!ecklist for evaluators%

'!e ISO 9001 s!all requirements are included in ISO 900("#000 so t!at it will be easy to link t!em

to t!e more c!allenging s!ould performance improvement guideline statements of ISO 900(% ,any

of t!e #$0 individual s!ould statements are e7panded wit! a list of tasks or activities t!at s!ould

be considered for implementation%

Organi.ations may eit!er selfassess or !ire outside auditors to evaluate t!em against t!e ISO

900( criteria% ,any organi.ations conduct periodic selfassessments to provide fact based

information to management about !ow t!ey compare to performance improvement criteria and to

better determine w!ere additional resources s!ould be applied%

Using t!e ISO 900( criteria) organi.ations can assess t!e maturity of t!eir quality management

system *+,S- compared to worldclass performance% '!e selfassessment can be used to identify

opportunities for improvement% In fact) if t!e assessment team !as t!e necessary resources) its

members s!ould forecast t!e benefits of improving t!e +,S based on ISO 900( considerations% It

is not uncommon for assessment teams to be multidisciplinary%

Organi.ations commonly use quality award criteria) suc! as t!e ,alcolm :aldrige ational +uality

6ward program in t!e United States) to conduct selfassessments% Conducting an assessment using


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t!e ISO 900( criteria is not t!e same as using quality award criteria% :ut) if your organi.ation

conducted an ISO 900( assessment and wanted to move to t!e quality award criteria) it would be

like taking anot!er step up a ladder instead of needing a new ladder%

6ppendi7 6 in t!e ISO 900( standard contains useful information about selfassessments and a

maturity model to grade your organi.ation% Organi.ations can also use t!e &A questions provided in

6ppendi7 65 or develop t!eir own questions based on t!e s!ould statements% '!e appendi7 also

proposes benefits resulting from improvement actions%

:etter =isk 6ssessment

+,S standards are really a set of controls for specified activities or actions% '!e standards list

activities) processes or transformations t!at represent risk to organi.ations% 'o better manage

risk) organi.ations can compare t!e processes t!ey currently control to t!e new ISO 900(

processes and process en!ancements%

4er!aps measuring and monitoring customer satisfaction of all interested parties may be

appropriate to lower management risk% ISO 900( establis!es controls to measure satisfaction of

interested parties suc! as local government) regulators) suppliers) bankers) union officers and

partners% ISO 900( !as also added topics suc! as information and financial resource controls%

'!e writers of ISO 900( identified processes t!at could add value to an organi.ation% Since t!e

clause numbering of ISO 9001 and ISO 900( is t!e same for t!e first two number levels *$%( in

ISO 9001 is t!e same as clause $%( of ISO 900(-) it is easy to crossreference ISO 900( to

determine w!at controls could benefit your organi.ation%

'!e infrastructure *clause ;%5- and work environment *clause ;%(- criteria demonstrate !ow ISO

900( is more compre!ensive t!an ISO 9001 for assessing risk%

:uild a :usiness Improvement ,odel


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Organi.ations can use ISO 900( as a business model instead of !aving a separate quality system

and management or business system models% ISO 900( allows for considering bot! effectiveness

and efficiency of organi.ations% 2or most companies quality and organi.ational wealt! go !and in

!and% +uality is a vital business strategy for longterm profitability%

ISO 900( was not written by a university professor) nor was it created by a business or quality

guru% It is probably muc! better t!an anyt!ing a single professor could construct or an inventive

aut!or or speaker could create%

ISO 900( is t!e result of input from e7perts around t!e world% It passed multiple reviews and is a

consensus standard% It is w!at everyone on t!e international committee and voting member

countries agreed is important for performance improvement%

6ll t!e pet peeves and baseless inputs !ave been removed%

for solid and proven business controls% '!e ISO 900( guideline standard may not be as fun to read

as books suc! as '!e One ,inute ,anager)1 but managers) officers and business owners can count

on every sentence being important and deserving attention%

'!e parts of ISO 900( t!at do not apply to your organi.ation do not need to be added to your

business system% Once you determine t!e parts t!at will benefit your organi.ation) t!e same

process approac! as in ISO 9001 can be used to e7pand your business management system%

e7t you can develop measurable business obectives) not ust quality obectives% In fact) once

organi.ations implement ISO 9001) t!ey may ask w!y t!e quality obectives are different from t!e

business obectives% 6ren3t t!e quality obectives linked to business risk and opportunity for

improvement>

@n!ance ,anagement =eview

Using ISO 900( at management reviews and during management planning will add value% ,ost of

ISO 9001 improvement is reactingto customer complaints) audit findings and daily process


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management issues% ISO 900( is a proactive tool used to evaluate and improve t!e suitability of t!e

+,S% '!e comparison of your +,S to ISO 900( at management reviews will result in

recommendations for improvement t!at will c!ange t!e e7isting system% Use of ISO 900( criteria

will lead to preventive action and continual improvement%

:ecause ISO 900( links financial benefit *efficiency- and t!e +,S) t!ere is greater buyin from

top management% ISO 900( also brings out potential upsides t!at will improve competitiveness%

Sure) management wants to maintain w!at it !as) but its real need is to stay competitive in an ever

c!anging business environment%

Its writers recogni.ed ISO 900(3s usefulness in promoting continual improvement) so 6ppendi7 :

provides t!e steps to follow) w!et!er for small step ongoing improvement or breakt!roug! proects%

6ssess Suppliers

,any organi.ations !ave been using ISO 900( criteria to evaluate t!eir suppliers% '!e criteria are

toug!) but organi.ations will know a lot more about t!eir current or potential partners3 strengt!s

and weaknesses%


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Standards play a role during bot! war and peacetime

by 8ale % Hordon

'!is mont!3s column will be a bit unusual in t!at it does not look forward so muc! as look back% I am

writing as t!e conflict in Iraq is winding down and t!e considerable military mig!t of t!e United

States and ot!er coalition forces was able to bring down t!e regime of a despot in t!e ,iddle @ast%

reflects on !ow t!e developed world) and t!e United States) in particular) !ave t!e tec!nological

ability and resources to e7tend t!eir influence globally% It certainly takes great leaders!ip) but italso takes great capabilities in manpower) materials and manufacturing%

,y daug!ter !as acquired a taste for !istory in addition to !er ot!er sc!olastic interests% '!is is

t!e same interest I enoyreading and understanding !ow societies and civili.ation !ave c!anged)

progressed and) in some cases) regressed t!roug!out t!e ages% ast C!ristmas s!e gave me a book

by t!e late Steven @% 6mbrose) a noted !istorian and a prolific writer about 6merican !istory%1

book !e sums up !is researc! and ot!er facts and events related to 6merican leaders% So w!at does

t!is !ave to do wit! standards) you ask>

6s I read t!is book and was simultaneously attuned to world events) I reali.ed !ow t!e confluence

of tec!nology and political events !as c!anged modern politics and t!e ability of nations to proect

t!eir ideas well beyond t!eir borders% '!e book also s!ows t!e role standardi.ation !as played in

t!is ability%

'!e 6merican Civil


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I am sure some !istorians would argue t!is !as been true since man made s!arp tools or discovered

metals%

+uality and


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,ost of t!e advances in manned flig!t *#005 being its 100t! anniversary- !ave come from

investments primarily funded by military activity%

political environment in w!ic! we live today% :ut in t!e #0t! century *and possibly into t!e #1st-) t!e

!arnessing of tec!nology and applications of industrial processes !ave broug!t t!e world toget!er

and made it a smaller place% '!roug! standardi.ation we are beginning to be!ave as unified

peoplesusing a common language not only in commerce but also in politics%

Standardi.ation is not meant to stifle innovation or subvert progress% +uite t!e opposite) it is

intended to remove variation in processes) w!ic! can cause failure) poor performance) and

disagreements or friction between parties%


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Standards 8evelopers

8eveloping and producing standards is not ignoble work) nor is it likely to be a maor part of

!istory% Standards won3t bring fame and fortune to t!eir creators% :ut t!e men and women involved

in suc! efforts tend to view standards creation as a wort!y and fulfilling endeavor benefiting a

larger w!ole and a greater good%


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'!ere !as been increased interest in t!e process approac! ever since ISO 9001 was issued in

8ecember #000% It is a good approac! w!et!er you are interested in International Organi.ation for

Standardi.ation) known as ISO) standards or not%

One of t!e clever tools we can use to develop t!e process approac! is t!e plandoc!eckact

*48C6- cycle% 6ctually) we can say applying t!e 48C6 cycle to !ow we do business is t!e process

approac!%

'!e ISO standards community !as provided several guidance documents to !elp organi.ations

implement and better understand t!e requirements in t!e ISO 9001 standard% '!ese documents

are free to anyone) but unfortunately t!e guidance documents are seldom used%

One of t!e documents providing guidance on t!e process approac! is being revised%1 '!e revised

document is likely to delete a section I find particularly !elpful for auditing and implementing t!e

process approac!% I am concerned t!at once t!e revised document is issued) t!e original version3s

valuable implementation question section may not be available for referencing%

'o preserve t!e implementation questions section for future reference) I will s!are my version of

t!ese questions wit! you in t!e remainder of t!is column%

'!e +uestions

'!e requirements for t!e quality management system *+,S- are defined in clause (%1 of ISO

9001"#000% '!e following questions) identified by 48C6 stage and by ISO 9001 clause) could be

used by t!ose wanting to implement or audit t!e systemprocess approac! of an organi.ation%

4lan(%1a% Identify t!e processes needed for t!e +,S and t!eir application t!roug!out t!e

organi.ation"

6re t!e processes needed for t!e management system defined>

6re t!e customers of eac! process *internal and e7ternal- identified>


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6re t!e customer requirements known>

6re t!e process owners identified>

6re any of t!e +,S processes outsourced to ot!er organi.ations>

6re t!e inputs and outputs for eac! process defined>

4lan(%1b% 8etermine t!e sequence and interaction of t!ese processes"

Is t!e overall flow of t!e processes known>

6re t!e sequence and interaction of processes described in some manner suc! as process flow

diagrams) process maps) flowc!arts or ot!er means>

?ave t!e interfaces between processes been identified>

?ave documentation needs been decided>

4lando(%1c% 8etermine criteria and met!ods required to ensure bot! t!e operation and control of

t!ese processes are effective"

6re t!e c!aracteristics of t!e intended and unintended process results known>

6re t!ere criteria for monitoring) measurement and analysis>

6re economic issues *cost) time and waste) for e7ample- considered>

6re t!ere met!ods for data gat!ering>

6re criteria and met!ods considered during management system planning> ?ow>

4landoc!eck(%1d% @nsure t!e availability of resources and information needed to support t!e

operation and monitoring of t!ese processes"

6re resource needs defined for eac! process>

6re t!e communication c!annels defined>

8oes t!e organi.ation provide internal and e7ternal information about t!e process> ?ow is it done>

Is feedback obtained> ?ow is it done>

6re needed process data defined>

6re needed records defined>

4landoc!eck(%1e% ,easure) monitor and analy.e t!ese processes"


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Is process performance *process capability) customer satisfaction- measured> ?ow is it done>

6re necessary measurements determined>

Is t!e gat!ered information analy.ed> ?ow is information analy.ed *statistical tec!niques->

6re t!e results of analysis known>

4landoc!eckact(%1f% Implement action necessary to ac!ieve planned results and continual

improvement of t!ese processes%

6re t!e processes improved> ?ow are t!ey improved>

6re necessary correctivepreventive actions identified>

6re correctivepreventive actions implemented>

6re correctivepreventive actions effective> ?ow is effectiveness determined>

2unction vs% 4rocess

,ost businesses and organi.ations start off using t!e process approac!) but as t!ey grow)

functional departments are formed% ,anaging by department or function leads to more emp!asis on

function performance and less on t!e processes for providing a value added product or service and

ac!ieving customer satisfaction%

questions can identify management system opportunities% Organi.ations t!at use t!e system

approac! to management benefit in t!e following ways"#

'!eir processes are integrated and aligned%

'!ey !ave t!e ability to focus efforts on key processes%

'!ey !ave greater confidence t!ey are operating in a consistent) effective and efficient manner%

Quality Excerpts 2003

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Transcript of Quality Excerpts 2003